Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error regarding sterilization temperatures without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Stryker Endoscopy is recalling 147,921 units of Stryker Irrigator Reusable Tips (Manufacturer Part Number 250-070-411). These suction irrigator tips are used to aid in cleaning and clearing the operative site during laparoscopic surgery. The recall covers all sizes of the product.
The recall was initiated because the Instructions for Use incorrectly listed the pre-vacuum steam sterilization (wrapped method) temperature as 121-123°C, instead of the correct 132-133°C. This labeling error could result in improper sterilization of the device.
The affected products were distributed worldwide, including in the United States and numerous other countries such as Mexico, Canada, Japan, and Australia. Healthcare facilities and users should stop using the affected tips and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
- Manufacturer
- Stryker Endoscopy
- Affected units
- 147,921
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufacturer Part Number: 250-070-411
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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